Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole

May 14, 2019 updated by: Umeå University
This study will examine if a single dose of Ciprofloxacin and Trimethoprim/Sulfamethoxazole are equivalent for prophylaxis immediately prior to prostate biopsy, when a patient has a suspected prostate cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: The number of prostate biopsies are estimated to approximately 1.000.000 each year I Europe1. The infection rates after transrectal prostate biopsy are increasing annually2. The most common antibiotic used for prophylaxis is Ciprofloxacin, however, Trimethoprim/Sulfamethoxazole is also a feasible alternative3.

Aim: To evaluate the best antibiotic prophylaxis prior to trans rectal prostate biopsy in low risk patients.

Outcome: Hospitalization for infection within 14 days from biopsy.

Method: By randomization of all eligible patients with low risk of infectious complications. Patient and treating physician is blinded to treatment allocation. By using the nationwide and full coverage national patient register (NPR), mandatory for inpatient care4. All patients can be identified by the Swedish personal identification number5. Both patients related baseline characteristics is gathered through register linkages. To validate the outcome variables, for all patients admitted to hospital within 14 days will be subject for chart review. Comparing all patients from the participating units, having a code specific to trans rectal biopsy, and comparing to the excluded patients as well as included patients, will make a separate exclusion analysis.

The standard operating procedure for randomization is that patients will fill a form and informed consent of participation prior to the planned biopsy. If no exclusion criteria are filled and informed consent obtained, patient will be randomized through a web based randomization program, where only date of biopsy, earlier prostate biopsy, number of biopsies, PSA and prostate size is collected. Other baseline variables will be obtained by cross linkage to the NPR and the National Prostate Cancer Registry. A randomization number is given to all patients at this stage and a key code is established at each participating unit containing every patient randomization number and subsequent personal identification number.

After complete requirement, data will be collected at Västernorrlands Läns Landsting and analyzed according to protocol.

Analysis will be made by logistic regression and point estimates with Single sided 97.5% Confidence Interval. Sample size is calculated to require 2800 patients assuming a 0.5% frequency of infections, able to detect a difference of 0.75% in absolute proportion of infections.

Missing data on outcome variable, received treatment or date of biopsy will be excluded from analysis.

Study Type

Interventional

Enrollment (Anticipated)

2800

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Helsingborg, Sweden, 25187
        • Not yet recruiting
        • Helsingborgs Hospital
        • Contact:
          • Magnus Wagenius, M.D
      • Umea, Sweden, 90185
      • Ängelholm, Sweden, 26281
        • Not yet recruiting
        • Ängelholm Hospital
        • Contact:
          • Magbus Wagenius, M.D
    • Jämtland
      • Östersund, Jämtland, Sweden, 83130
    • Västernorrland
      • Sundsvall, Västernorrland, Sweden
        • Recruiting
        • Sundsvalls hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Indication for trans rectal prostate biopsy (Physicians discretion)
  • Informed consent

Exclusion Criteria:

  • Diabetes Mellitus
  • Indwelling urinary catheter
  • Prior urinary infection (last 6 months)
  • Dipstick positive (Nitrites test)
  • Allergy to Ciprofloxacin or Trimethoprim/Sulfamethoxazole
  • Severe liver disease
  • Concomittant use of Tizanidine
  • Immunosuppression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ciprofloxacin
T. Ciprofloxacin 750mg, single dose immediately prior to prostate biopsy
Drug: Ciprofloxacin
Active Comparator: Trimethoprim/Sulfamethoxazole
Trimethoprim/Sulfamethoxazole 160mg/800mg immediately prior to prostate biopsy
Drug: Trimethoprim/Sulfamethoxazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Admitted to hospital due to infection
Time Frame: 14 days
Admission to hospital within 14 days from biopsy
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Filled antibiotic prescription
Time Frame: Within 30 days
A filled prescription within 14 days from biopsy
Within 30 days
Positive urinary or blood culture
Time Frame: Within 30 days
A positive urinary or blood culture obtained within 14 days from biopsy
Within 30 days
Any hospital admission
Time Frame: Within 14 days
Admission to hospital within 14 days from biopsy, regardless of cause
Within 14 days
Overall Mortality
Time Frame: Within 90 days
Overall mortality within 90 days from biopsy
Within 90 days
Bacteriological characteristics
Time Frame: Within 30 days
Resistance patterns and species of bacteria in blood or urinary cultures within 14 days from biopsy
Within 30 days
Hospitalisation time
Time Frame: Within 14 days
Number of days admitted to hospital
Within 14 days
Total doses of antibiotics filled
Time Frame: Within 30 days
The total amount of antibiotics filled
Within 30 days
Risk factors for infection
Time Frame: Within 30 days
Other risk factors for infection apart from exclusion criteria, in baseline variables
Within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Johan Styrke, M.D, Ph.D, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

April 6, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014---002999---83

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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